Navigating Clinical Immunogenicity of LNPs: Regulatory Guidelines & Clinical Management in Human Trials
Time: 3:01 pm
day: Pre-Conference Workshop Day
Details:
- Explore the regulatory framework surrounding the assessment of clinical immunogenicity of complex biologics, including those delivered via LNPs, ensuring compliance with guidelines and standards set forth by regulatory authorities
- Discuss strategies for effective clinical monitoring of immunogenicity in human trials, including sample collection, and data interpretation to identify, manage, and mitigate potential risks and ensure patient safety
- Discuss how the integrated immunogenicity data from clinical trials and the proposed management and mitigations may impact the label
